The Clinical Protocol and Data Management arm of UCLA's Jonsson Comprehensive Cancer Center (JCCC) is administered by the JCCC Clinical Research Unit (CRU). The CRU was established in 1993 as the first major facility for support of clinical cancer research at UCLA. The establishment of this unit was critical to move the Division of Clinical/Transitional Research of the JCCC and its investigators into a position from which it could play a significant role in investigator-initiated, cooperative group and industry-sponsored clinical research in cancer. Data Safety and Monitoring is also contained in this section of our proposal and is overseen by the JCCC Office of Regulatory Compliance (ORC). The ORC is a separate entity within the JCCC that manages our protocol review and monitoring activities and is responsible for reporting to CTRP and clinicaltrials.gov.